Urinalysis is a common method used by medical professionals to diagnose a patient. It is a laboratory test performed to determine problems with a patient with factors that can appear in urine. These factors can be characteristic of many illnesses and disorders that affect how the human body removes waste and toxins. Problems with any of the lungs, kidneys, urinary tract, skin, and bladder can affect the appearance, concentration, and content of urine.
In order to obtain urine from a patient, the patient is often required to urinate into a container. These containers are typically known as urine collection devices (UCDs). After obtaining samples in these containers, medical professionals often are required to transfer the urine from the containers into vials or storage tubes for analysis, often through an intermediary transfer cup. This process is inefficient, poses a threat to contaminating the sample, and increases the risk of body fluid exposure to persons handling the sample. The terms “vials” and “storage tubes” are used, herein, interchangeably.
Spilling urine during transfer of the collected sample to the transfer cup is a common occurrence. Directly pouring the urine into the transfer cup from the urine collection device can cause the cup to overflow or the urine to spill on the vial and/or container itself as well as any other surfaces nearby. This process can cause contamination of these surfaces, such as a laboratory table, and negatively affect the accuracy of the urinalysis and other tests performed on the same surfaces. Spilling urine can also cause the urine and another other infectious agents in the urine get on the medical professional's clothing, or other safety equipment, requiring them to change out of the contaminated articles. Labels on the outside of the UCDs as well as the transfer cups can become illegible when urine comes into contact with the ink on the label. These occurrences require additional time and effort to remedy as well as excess use of supplies.
Some attempts at resolving the above issues have been made. U.S. Pat. No. 4,026,433 (Crippa) describes a testpiece that is tightly coupled to a downwardly extending tubular member of a glass receptacle with a cover. The urine is collected by the glass receptacle and then the cover is fitted over it. The testpiece is physically attached to the glass receptacle over the outside of the tubular member, and then liquid is transferred to the testpiece by tilting the receptacle to allow the urine to flow over the edge of the tubular member into the testpiece. However, if any urine seeps into the interface area where the tubular member and testpiece facilitate attachment, the tight coupling of the two pieces will become undone and the testpiece could fall off.
U.S. Pat. No. 4,492,258 (Lichtenstein) discloses a collection apparatus with a collection chamber for a sample of urine. Once the collection chamber is filled with fluid, the excess urine is collected in a container surrounding the chamber. A drain passage is connected to the excess urine container for runoff urine to flow once the container is filled. The urine in the collection chamber, however, still needs to be transferred into an analysis vial for testing.
U.S. Pat. No. 7,871,385 (Levinson) describes another collection apparatus with a collection chamber for a sample of urine. Once, the collection chamber is full, a ball within the chamber will close off the opening to the chamber and thus prevent any further urine to enter the chamber. This extra urine is then passed through an opening at the end of the apparatus into either another container or disposal. Transfer of the urine in the collection chamber to an analysis vial for testing still presents a problem.
One prior art process of transferring urine from a UCD to an analysis vial is illustrated in FIGS. 1A to 3. FIG. 1A shows an analysis vial 101. The interior of the tube is maintained at a vacuum and is sealed by stopper 102. An optional volumetric grid (not shown) and label 115 may be seen on the outer surface of the analysis vial 101.
FIG. 1B shows a transfer cup 103. The transfer cup has a body portion 104 typically made of plastic, though other materials can be used such as glass. The transfer cup also consists of a screw cap 105, containing an integrated transfer apparatus 106, for closing the cup. A label 107 covers the opening to the integrated transfer apparatus 106 in the screw cap 105 and can be peeled back to expose a needle 108 in the center of the opening. The needle is contained in a rubber sheath (not shown), which if pushed towards the lid exposes the needle for fluid transfer. For example, when the analysis vial is pushed against the transfer cup to insert the needle of the transfer cup in the analysis vial, the rubber stopper is pushed back and exposes the needle. FIG. 1C shows a transfer straw 109 that can be used with transfer cup 103 instead of the integrated transfer apparatus 106 in screw cap 105. The transfer straw 109 is a non-sterile, plastic holder device that contains a needle 111 that is held in place by a portion 110 of the plastic holder device. Needle 111 is surrounded by a rubber sheath 115, which can be retracted by pushing an analysis vial towards the needle 111. FIG. 1D shows another type of urine collection device, a urinal 112, which can be used for urination by bedridden patients. It is sometimes necessary to collect a sample from the urinal of a bedridden patient. The body of the urinal is ribbed for strength and has an optional measurement grid (not shown) to determine the volume of the fluid inside. The urinal 112 has an opening 113 for urine to enter when in use and has an optional lid (not shown) over opening 113 to prevent spilling and reduce odor. The opening 113 is angled from the main body of the urinal for ease of use. A handle 114 also extends from the main body of the urinal for convenience purposes. FIG. 1E shows a female adapter 115 for the urinal 112.
FIG. 2 shows a prior art method of collection of urine and transferring a sample to an analysis vial using the devices illustrated in FIGS. 1A to 1D and is illustrated in FIG. 3. In Step 200, urine is collected in urinal 112. Arrow 116 represents the flow of urine into the urinal, in which the urine 115 collects at the bottom of the container. In Step 202, urine 115 is transferred from the urinal 112 to the body portion 104 of the transfer cup 103. In Step 204, urine 115 is transferred to the analysis vial 101 from the transfer cup 103. This can be performed either with the integrated transfer apparatus 106 in the screw cap 105 of the transfer cup 103 or using a transfer straw 109 placed in the urine 115 in the body portion 104 of the transfer cup 103. The analysis vial 101 is pushed stopper 102 side down into either the opening in the screw cap 105 or into the opening in the top of the transfer straw 109. The needle 111 located in the integrated transfer apparatus 106 and the transfer straw 109 punctures the stopper 102 and urine 115 enters the interior of the analysis vial 101 from the needle 111. Once an adequate amount of urine 115 enters the analysis vial 101, the analysis vial is pulled from away from the transfer cup 103, sealed, labeled, and stored.
In some methods of urine collection, the transfer cup 103 acts as the urine collection device, and the urinal 112 is not used. However, this method results in splashing and spilling of the urine while the patient urinates into the cup more frequently.
This method presents several contamination and safety threats. The urine could be spilled from transfer from the urinal to the transfer cup. Using multiple devices increases the potential that one of those devices has been exposed to a contaminant and would thus introduce a contaminant to the urine in any of the devices. Since a needle is present within the integrated transfer apparatus in the screw cap of the transfer cup and within the transfer straw, safety concerns are raised with regards to accidentally puncturing the gloves or skin of medical professionals handling the transfer of urine to the analysis vials. A more streamlined and efficient apparatus is needed for the transfer of urine from a urine collection device to an analysis vial.